Biologic medications: Why are they so expensive?

Biological medications, or biologics, are drugs that come from living organisms.

They are a relatively newer kind of medication for treating a variety of chronic health conditions, like autoimmune diseases, cancer, and irritable bowel syndrome (IBS).

Manufacturers often give biologics brand names, but sometimes these medications also have generic versions, called biosimilars.

Both types of medication are often expensive because of the research and development that goes into producing them. 

What are biologics and biosimilars?

Biologic medications are made from living organisms like plant and animal cells and microorganisms. First approved by the Food and Drug Administration (FDA) in the 1980s to treat diabetes, biologics have advanced to treat a variety of conditions.

These conditions include:

• cancer
• autoimmune disorders
• kidney disease
• cardiovascular issues
• arthritis
• IBS
• macular degeneration

According to the FDA, biologics are sometimes the most effective treatment for various conditions. These medications can come in several forms and products, such as:

• vaccines
• blood and blood components
• cell therapies
• gene therapy tissues
• therapeutic proteins

Biosimilars

Biosimilars are the generic version of biologic medications.

They are made to mimic and be similar to biologics that have already received FDA approval. Biosimilars must work in the same way as the biologics they’re mimicking. They must also have the same potency and safety.

Biosimilars may have minimal differences, but they should not affect how the drugs work, their effectiveness, or their safety. Biosimilars must undergo the same rigorous testing as biologics to receive FDA approval. 

Why are biologics so expensive?

Biologics are expensive because they’re highly complex medications. This means that the research, development, manufacturing, testing, and approval processes are more difficult and time-consuming than for other medications. 

They contain around 25,000 atoms. A medication like aspirin, on the other hand, contains 21 atoms.

And because the ingredients come from living organisms, scientists must reproduce, grow, copy, extract, and purify them in a lab to create the final drug product. 

This also means that batches of biologics are not identical. This adds complexities and costs because manufacturers must ensure that each batch acts in the same way and has a predictable effect on all people who take the medication. 

Developing and manufacturing new therapeutic and biologic medication can cost around $1.1 billion.

About biosimilars

When manufacturers create a biosimilar medication, they base the drug on the biologic version, called a reference product. Biosimilars mimic the reference product’s effects, purity, and safety.

A biosimilar’s active ingredients are typically the same as those in the reference product. Yet a biosimilar may have different binders and inactive ingredients. Inactive ingredients are those that can preserve, lubricate, flavor, or color a medication, and binders hold them all together.

All biosimilars must meet FDA criteria of purity, potency, and safety.

For example, adalimumab (Humira) is a biologic medication for chronic conditions like rheumatoid arthritis, psoriasis, ulcerative colitis, and Crohn’s disease. Humira has several biosimilars, including adalimumab-atto (Amjevita), adalimumab-adaz (Hyrimoz), and adalimumab-afzb (Abrilada). 

A key difference between biologics and biosimilars is that biosimilars are often less expensive — sometimes 15–35% cheaper than their reference product. But they are still expensive compared to nonbiologic drugs.

The research and development of a biosimilar is significantly less than that of a biologic, but it can still be between $100 and $250 million.

Biologic medications vs. traditional medications

Biologic and biosimilar medications have key differences from nonbiologic drugs. These include:

• Production: Biologics and biosimilars are made with living organisms. Manufacturers develop and produce conventional medications using synthetic and chemical processes.
• Complexity: Biologics and biosimilars are known as large-molecule medications because they’re highly complex and can have more than 25,000 atoms. Nonbiologic medications can have as few as 21 atoms. 
• Reproducibility: No batch of biologic and biosimilar medication is identical to the next. Additional processes exist to ensure their effects are the same and they behave predictably. Synthetic and chemically processed drugs, on the other hand, can be produced and reproduced identically.
• Development cost: Development and manufacturing of a biologic medication can cost up to $3 billion. Biosimilars can cost up to $250 million. This is compared with the $1–4 million it costs to develop and manufacture generic nonbiologic medications. 

Common biologic medications 

Some common biologic mediations include:

• Adalimumab (Humira): Adalimumab (Humira) is an injectable medication for conditions like rheumatoid arthritis, Crohn’s disease, ulcerative colitis, uveitis, psoriasis, and ankylosing spondylitis. These are typically inflammatory conditions, and adalimumab works by blocking molecules that cause inflammation. 
• Secukinumab (Cosentyx): Secukinumab (Cosentyx) is also an injectable biologic medication. It treats psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis. Secukinumab works by blocking a substance that causes inflammation in the body. 
• Rituximab (Rituxan): Rituximab (Rituxan) injections help treat certain autoimmune diseases, like rheumatoid arthritis, and certain types of cancer, like leukemia. Rituximab’s job is to kill cancer cells and prevent the immune system from damaging joints and blood vessels. 
• Bevacizumab (Avastin): Bevacizumab (Avastin) injections treat some types of cancer, such as colon, cervical, and nonsmall cell lung cancer. Bevacizumab stops blood vessels from forming that would take oxygen to tumors. 
• Insulin glargine (Lantus): Insulin glargine (Lantus) helps treat type 1 diabetes by increasing insulin levels and stopping the liver from producing more sugar. 

If you are thinking about how to manage medication costs, depending on your health condition, a doctor may be able to offer more affordable medications with the same rate of effectiveness.

If you need help covering the cost of medications, the free Optum Perks Discount Card could help you save up to 80% on prescription drugs. Plus, you can now get them delivered to your home in as little as 3 days. Search for your medication here.

Is there any help available for biologic costs?

Biologic medication is expensive. For example, Humira can cost around $740 per 40 milligram (mg) injection. If you have health insurance, the plan may cover some or all of the costs. It’s best to check your plan’s drug list, called a formulary, for full details.

If you don’t have insurance, you may consider certain measures to cut costs:

• Consider a biosimilar: Ask a healthcare professional whether you can use a biosimilar version of the medication.
• Assistance programs: Both federal and state medication assistance programs may help with the cost of your medications. 
• Coupons and savings cards: Look out for manufacturer-issued coupons and prescription drug savings programs, like the free Optum Perks Discount Card that can help you save up to 80% on some prescription medications.

Summary

Biologic medications are made from living organisms through a complex and lengthy process. Although they are highly effective for treating certain chronic conditions, their cost remains high.

These medications are difficult to develop and manufacture, and their testing and regulatory processes are more exhaustive than those of more conventional medications. This leads to their high cost.

If you’ve been prescribed a biologic medication, you may have some options to help lower the cost, such as federal and state assistance programs, manufacturer and pharmacy coupons, and medication savings cards. 

Download the free Optum Perks Discount Card to save up to 80% on many prescription medications. Plus, you can now get them delivered to your home in as little as 3 days. Search for your medication here.